JAMP AMOXI CLAV TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE); CLAVULANIC ACID (CLAVULANATE POTASSIUM)

Tilgængelig fra:

JAMP PHARMA CORPORATION

ATC-kode:

J01CR02

INN (International Name):

AMOXICILLIN AND BETA-LACTAMASE INHIBITOR

Dosering:

250MG; 125MG

Lægemiddelform:

TABLET

Sammensætning:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 250MG; CLAVULANIC ACID (CLAVULANATE POTASSIUM) 125MG

Indgivelsesvej:

ORAL

Enheder i pakken:

15G/50G

Recept type:

Prescription

Terapeutisk område:

AMINOPENICILLINS

Produkt oversigt:

Active ingredient group (AIG) number: 0234720008; AHFS:

Autorisation status:

APPROVED

Autorisation dato:

2020-11-20

Produktets egenskaber

JAMP Amoxi Clav (Amoxicillin and Clavulanate Potassium Tablets) Page 1
of 37
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
JAMP AMOXI CLAV
Amoxicillin and Clavulanate Potassium Tablets
JAMP Amoxi Clav -250 tablets
250 mg amoxicillin (as trihydrate) and 125 mg clavulanic acid (as
clavulanate potassium), Oral
JAMP Amoxi Clav -500F tablets
500 mg amoxicillin (as trihydrate) and 125 mg clavulanic acid (as
clavulanate potassium), Oral
JAMP Amoxi Clav -875 tablets
875 mg amoxicillin (as trihydrate) and 125 mg clavulanic acid (as
clavulanate potassium), Oral
House Standard
COMBINATIONS OF PENICILLINS, INCLUDING BETA-LACTAMASE INHIBITORS
ATC CODE: J01CR02
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Date of Initial Authorization:
November 20, 2020
Date of Revision:
August 3, 2023
Submission Control Number: 272812
JAMP Amoxi Clav (Amoxicillin and Clavulanate Potassium Tablets) Page 2
of 37
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Immune
08/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
..........................................................................................
2
TABLE OF CONTENTS
............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1
INDICATIONS
............................................................................................................
4
1.1
Pediatrics
..................................................................................................................
4
1.2
Geriatrics
..................................................................................................................
4
2
CONTRAINDICATIONS
...............................................................................................
5
4
DOSAGE AND ADMINISTRATION
...............................